试验用药品管理中存在的问题及解决对策

Discussion on the Problems and Countermeasures in the Management of Experimental Drugs

目的促进临床试验用药品管理水平,保证临床试验的质量。方法调取2015年5月至2021年5月机构药品管理员对本院承接43个项目共43次试验用药品管理中发现的问题进行汇总分析,并提出改进措施及相关建议。结果汇总不合格项共22项,共计61个。药物的接收、发放、回收、使用是试验药物管理中问题发生率最高的四个环节。提出改善试验用药品的管理流程、修订完善试验用药品管理制度及标准操作规程、重视试验药品管理的细节、注重试验药物重要环节的管理、建立试验药物信息化管理系统的改善对策。结论试验药物中心化管理模式的建立和专职药师的参与有利于规范试验用药品的管理、提高试验用药品管理水平,保证药物临床试验过程真实规范、结果科学可靠。

OBJECTIVE To promote the management of clinical trial drugs and to guarantee the quality of clinical trials.METHODS From May 2015 to May 2021,the institutional drug administrator summarized and analyzed the problems found in the management of 43 trial drugs in 43 projects undertaken by our hospital,and put forward improvement measures and relevant suggestions.RESULTS A total of 61 items were found in 22 cases.The receiving,distribution,recovery and use of drugs are the four links with the highest incidence of problems in the management of experimental drugs.The improvement measures included improving the management process of experimental drugs,formulating and constantly improving the relevant drug management system and standard operating procedures(SOP),paying attention to the management of details and important links of experimental drugs,and establishing the information management system of experimental drugs.CONCLUSION Centralized management is beneficial to standardize the management of investigational drugs,so as to improve the management level of investigational drugs,and ensure that the clinical trials of drugs are truly standardized and the results are scientific and reliable.